Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1031-2018·Announced 2018-03-21

Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surface.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential contamination (residue) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling 13,227 units of CR-FLX POR HATCP FEM implants. These devices are indicated for patients with severe knee pain and disability. The recall covers various highly polished hip and knee implant models distributed worldwide, including in the United States and numerous international markets.

The recall was initiated because the LDPE bag packaging for these implants may adhere to the highly polished surface. This adhesion can leave residue or material from the LDPE bag on the implant after it is removed from the packaging.

Consumers and healthcare providers should check their inventory for the specific catalog and lot numbers listed in the official recall notice. If you have these implants, contact Zimmer Biomet or the FDA for instructions on how to proceed.

The recalled product

Product: CR-FLX POR HATCP FEM C-L MINUS CR-FLX POR HATCP FEM C-R MINUS CR-FLX POR HATCP FEM D-L MINUS CR-FLX POR HATCP FEM D-R MINUS CR-FLX POR HATCP FEM E-L MINUS CR-FLX POR HATCP FEM E-R MINUS CR-FLX POR HATCP FEM F-L MINUS CR-FLX POR HATCP FEM F-R MINUS CR-FLX POR HATCP FEM…
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: contamination
packaging-defect
Affected units: 13,227

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 48 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 48 products in this recall →

Same manufacturer · Zimmer Biomet, Inc.

See all →

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High
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Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
High
Zimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11

Same hazard · contamination